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New FDA Commissioner Hits the Ground Running

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

Recent Amendments to New York’s Not-For-Profit Corporations Law

Time to Update Your Corporate Bylaws? New York Gov. Andrew Cuomo signed the New York Non-Profit Revitalization Act of 2013 (Act), into law in December 2013, thereby adopting important changes to the governance of...more

FDA Takes Steps to Declare Partially Hydrogenated Oils No Longer GRAS and Seeks Comments

On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are...more

11/8/2013  /  FDA , Food Safety , Trans Fat

FDA Submits Final Guidance on Mobile Medical Apps

Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more

10/4/2013  /  FDA , FDCA , Medical Devices , Mobile Apps

Supreme Court Game-Changer: Rule of Reason Applies to ANDA Reverse Payment Settlements

In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more

Medical Device Industry Responds to FDA's Overseas Clinical Trial Proposed Rule

In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more

6/17/2013  /  Clinical Trials , FDA , Medical Devices

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

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